FDA Product Code QZB: Software Controlled Endoscope And Instrument Holder
To Hold And Position Endoscopes And Instruments.
Leading manufacturers include Moon Surgical and Aktormed GmbH.
4
Total
4
Cleared
173d
Avg days
2024
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
126d
recently vs 314d historically
FDA 510(k) Cleared Software Controlled Endoscope And Instrument Holder Devices (Product Code QZB)
4 devices
Cleared
Jun 27, 2025
Maestro System (REF100)
Moon Surgical
General & Plastic Surgery
88d
Cleared
Mar 14, 2025
Maestro System (REF100)
Moon Surgical
General & Plastic Surgery
220d
Cleared
Aug 08, 2024
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499)
Aktormed GmbH
General & Plastic Surgery
314d
About Product Code QZB - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QZB since 2024, with 4 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QZB Product Code
Recent submissions under QZB have taken an average of 126 days to reach a decision - down from 314 days historically, suggesting improved FDA processing for this classification.
QZB devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →